FDA Orange Book
Generic for Delta-cortef
Delta-cortef contains prednisolone. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Delta-cortef is prednisolone. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
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Delta-cortef products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 5MG | Discontinued | None | 4 | BX, AB |
NDA 009987, held by PHARMACIA AND UPJOHN CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic prednisolone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 215673 | AB (A-rated, therapeutically equivalent) | March 17, 2023 | 5MG |
| ZHEJIANG XIANJU PHARMACEUTICAL CO LTD | 218083 | AB (A-rated, therapeutically equivalent) | May 2, 2024 | 5MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 080531 | BX (B-rated, not considered equivalent) | Approved Prior to Jan 1, 1982 | 5MG |
| WATSON LABORATORIES INC | 080354 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 5MG |
Questions
Is there a generic for Delta-cortef?
Yes. The generic name for Delta-cortef is prednisolone. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
What is the generic name for Delta-cortef?
The active ingredient in Delta-cortef is prednisolone, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.